As published in The Hill
By B. Douglas Hoey, RPh, MBA
CEO, National Community Pharmacists Association
When there is a national crisis, there's often a notion to pass legislation to try to prevent a recurrence from ever happening again. Now, in the wake of the tragic meningitis outbreak allegedly caused by tainted medications from a rogue drug manufacturer, some in Congress are looking to take action. While there may be room for a carefully crafted legislative solution, the situation calls to mind the time-tested, medical-school adage: First, do no harm.
In the event of the meningitis outbreak allegedly caused by the New England Compounding Center (NECC), it is important that Congress take targeted action to address the root cause of the problem. Overly broad legislation could have unanticipated consequences for patients and small business community pharmacies. For starters, everyone should recognize that NECC appears to have acted as a small-scale manufacturer of prescription drugs, churning out many thousands of doses and without first obtaining the necessary prescriptions. That's a far cry from traditional pharmacy compounding.
In comments submitted to both the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee in conjunction with their recent hearings, the National Community Pharmacists Association (NCPA) drew clear contrasts between the activities reportedly performed by NECC and the individualized compounding performed by independent community pharmacies.
Independent community pharmacists compound special needs medications for individual patients where a commercial product is not available and in response to a physician's prescription request. This may include making a liquid form of a medication for patients who have trouble swallowing pills or flavoring a medication for pediatric patients. Compounding also helps alleviate drug shortages on a regular basis. Perhaps most notably, just a few years ago during the nationwide H1N1 flu outbreak, traditional compounding helped alleviate a drug shortage for the liquid form of Tamiflu for children.
As previously evidenced, traditional compounding plays an integral role in the healthcare system. According to a survey of NCPA members, 85% of independent pharmacies perform compounding on behalf of patients and 62% say compounding makes up no more than 5% of their business. While compounding is a small, niche service for most community pharmacies, it is vital to meet specific needs of patients.
Given traditional compounding's important role in the healthcare system, Congress should carefully consider any legislative changes. Such due diligence should start with an analysis of existing statutes and regulations.
Were existing state and federal laws and regulations properly enforced in the NECC case? Evidence suggests not, judging by congressional hearings and media reports. Had existing authorities been exercised and requirements been enforced, the NECC tragedy could have been greatly mitigated or possibly prevented altogether. In fact, current law allows the Food and Drug Administration (FDA) to identify and stop rogue drug manufacturers as NECC appears to have been.
As Congress moves forward, NCPA stands ready to work with policymakers to ensure that any new legislation or regulations address the critical issue of proper oversight of the manufacturing of prescription drugs and shutting down any outliers like NECC. This balanced approach will ensure that patients maintain access to individualized medications when needed and that independent community pharmacies remain part of the solution to lowering health care costs and alleviating drug shortages when applicable.
Let's be certain not to throw the baby out with the bathwater.
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